Two site infusion apparatus

ABSTRACT

An apparatus for use in delivering pain medication to separate locations from a single source of pressurized medication includes a valve housing, a cap, and a flexible diaphragm. The valve housing includes a first end and a second end and an inlet passage. The first end includes first and second outlet orifices. The cap has a closed end and an open end and is removably coupled to the valve housing at the open end. The flexible diaphragm is coupled between the cap and the valve housing and is movable from a closed position to an open position. The flexible diaphragm seals a pressure chamber from the first and second outlet orifices when in the closed position and opens the first and second outlet orifices to the pressure chamber when in the open position.

[0001] This application claims priority to U.S. Provisional Application Serial No. 60/451,161, filed Feb. 28, 2003, and is a continuation of U.S. patent application Ser. No. 10/461,939, filed Jun. 13, 2003, which is a Continuation in Part of U.S. patent application Ser. No. 10/083,266, filed Feb. 23, 2002, now U.S. Pat. No. 6,679,862.

TECHNICAL FIELD

[0002] The present invention relates generally to the delivery of a pulsatile fluid pulse, and more particularly, to an apparatus for controllably dividing a pulsatile fluid flow into two or more pulsatile fluid flows.

BACKGROUND OF THE INVENTION

[0003] It is sometimes desirable to deliver a fluid using a pulsatile fluid flow or series of pulses. For example, some medication delivery systems which utilize a series of pulsatile fluid pulses to deliver medication, are known in the art. Medication delivery systems may be used to deliver pain control medication and other medications intraoperatively or post-operatively, subcutaneously, and percutaneously to a patient after a surgical, or some other medical, procedure.

[0004] For example, U.S. Pat. No. 5,807,075 to Jacobsen et al. discloses a conventional medication delivery system that includes a base housing and a cassette. The base housing of the '075 patent houses electronic components, such as an electric motor, a power source, and an electronic controller, and the cassette of the '075 patent interacts with a supply of the medication to deliver the medication to the patient.

[0005] A further example of a conventional medication delivery system is disclosed in U.S. Pat. No. 4,650,469 to Berg et al. This patent discloses a medication delivery system that includes a control module and a reservoir module removably connected to the control module. The control module includes a pump mechanism, valves, a power source, electronic controls, and the like, and the reservoir module

[0006] It is known to use an electric motor in such medication delivery systems, where each revolution or cycle of the motor delivers a preset amount of medication. Such systems are known as positive displacement systems. In such systems, the flow of medication is not pressurized unless it meets a restriction.

[0007] Generally, conventional medication delivery systems provide a flow of medication through an output tube which then is delivered to the patient, as required. However in some procedures, medication is required at two locations with respect to the patient, for example, breast augmentation or reconstruction. Another such procedure where medication delivery is desirable at two sites is an autologous graft procedure where it is desirable to deliver medication at both the graft and the donor sites. If the medication provided by the delivery system is pumped through a “Y” connection, then the medication will not be delivered to each site or location evenly for several reasons. First, unequal pressure at the two infusion sites due to elevation or intracompartmental pressure sets up a siphon where flow occurs from the higher pressure side to the lower pressure side in the period between pulses. Furthermore, if the flow of medication on one side of the “Y” has a greater restriction than on the other side, back pressure may reduce or stop the flow of medication on that side. This is undesirable.

[0008] One solution would be to provide a check valve in each leg after the “Y” connection. This solution presents several problems, namely, there is a time delay added by the opening and closing of the check valve and differences in manufacturing tolerances contributing to the delay may also lead to uneven delivery of the medication. Furthermore, most check valves restrict flow when open, and unequal or uncontrollable variations in this restriction would lead to unequal flow.

[0009] Another solution would be to provide a large fluid resistor (small orifice) in each leg. Correctly sizing this orifice would cause the pressure to rise substantially higher than the downstream pressure differences. This pressure could be driven up over several pulses. If the pressure remained higher than the highest downstream pressure, no backflow due to siphoning could occur. Furthermore, the difference in the pressure drop in the two downstream legs could be controlled to remain relatively equal. This solution presents several problems. First, the maximum pressure reached to provide the necessary flow split accuracy can be very high. This can interfere with other pump features such as an occlusion alarm, and can cause sealing difficulties. Second, if the pump has a user selectable flow rate, the size of the glass orifice must be fixed to work with the lowest possible flow rate. This aggravates the maximum pressure problem should the pump be used at its highest flow rates.

[0010] The present invention is aimed at one or more of the problems set forth above.

SUMMARY OF THE INVENTION AND ADVANTAGES

[0011] In one aspect of the present invention, an apparatus for use in delivering pain medication to separate locations from a single source of pressurized medication is provided. The apparatus includes a valve housing, a cap, and a flexible diaphragm. The valve housing includes a first end and a second end and an inlet passage. The first end includes first and second outlet orifices. The cap has a closed end and an open end and is removably coupled to the valve housing at the open end. The flexible diaphragm is coupled between the cap and the valve housing and is movable from a closed position to an open position. The flexible diaphragm seals a pressure chamber from the first and second outlet orifices when in the closed position and opens the first and second outlet orifices to the pressure chamber when in the open position.

[0012] In another aspect of the present invention, an apparatus for use in delivering pain medication to separate locations from a single pulsatile flow of medication, is provided. The apparatus includes a valve housing having a first end and a second end. The first end includes first and second outlet orifices. The second end forms a pressure chamber. The valve housing further includes an inlet orifice coupled to the pressure chamber by an inlet passage. The first and second outlet orifices are coupled to the pressure chamber by first and second outlet passages, respectively. A cap has a closed end and an open end and is removably coupled to the valve housing at the open end. A flexible diaphragm is coupled between the cap and the valve housing and is movable from a closed position to an open position, the flexible diaphragm sealing the pressure chamber from the first and second outlet orifices when in the closed position and opening the first and second outlet orifices to the pressure chamber when in the open position. The second end of the valve housing and the flexible diaphragm form a pressure chamber. The valve housing further includes an inlet orifice coupled to the pressure chamber by an inlet passage. The first and second outlet orifices are coupled to the pressure chamber by first and second outlet passages, respectively.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Other advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:

[0014]FIG. 1 is a first isometric view of a two site infusion apparatus, according to an embodiment of the present invention;

[0015]FIG. 2 is a second isometric view of the two site infusion apparatus of FIG. 1;

[0016]FIG. 3 is a top down view of the two site infusion apparatus of FIG. 1;

[0017]FIG. 4 is a side view of the two site infusion apparatus of FIG. 1;

[0018]FIG. 5 is a bottom view of the two site infusion apparatus of FIG. 1;

[0019]FIG. 6 is a first cut-away view of the two site infusion apparatus of FIG. 1;

[0020]FIG. 7 is s second cut-away view of the two site infusion apparatus of FIG. 1;

[0021]FIG. 8 is a graph illustrating operating parameters of the present invention;

[0022]FIG. 9 is a first isometric view of a two site infusion apparatus, according to a second embodiment of the present invention;

[0023]FIG. 10 is a second isometric view of the two site infusion apparatus of FIG. 9;

[0024]FIG. 11 is a top down view of the two site infusion apparatus of FIG. 9;

[0025]FIG. 12 is a side view of the two site infusion apparatus of FIG. 9;

[0026]FIG. 13 is a bottom view of the two site infusion apparatus of FIG. 9;

[0027]FIG. 14 is a first cut-away view of the two site infusion apparatus of FIG. 9;

[0028]FIG. 15 is s second cut-away view of the two site infusion apparatus of FIG. 9;

[0029]FIG. 16 is an diagrammatical illustration of a tube set including the two site infusion apparatus of FIG. 9; and,

[0030]FIG. 17 is a second diagrammatical illustration of the tube set of FIG. 16.

DETAILED DESCRIPTION OF THE INVENTION

[0031] With reference to the drawings and in operation, the present invention provides an apparatus 10 for use in delivering pain medication to separate locations from a single pulsatile source of medication (or two site infusion apparatus). In one embodiment, the source of medication is a medication delivery system which includes a positive displacement pump (not shown). For example, the medication delivery system could include an electrical motor. The system is designed to deliver through a tube or inlet tube 12 a preset amount of medication every revolution or cycle of the motor. The rate at which medication is delivered may be set by varying the time between cycles of the motor.

[0032] In one aspect of the present invention, the two site infusion apparatus 10 is coupled to the output tube 12. The two site infusion apparatus 10, as discussed below, splits the medication delivered from the delivery system and delivers the medicine through first and second outlet orifices 14A, 14B.

[0033] The apparatus 10 includes a valve housing 16. The valve housing 16 includes a first end 18 and a second end 20. The first end 18 includes the first and second outlet orifices 14A, 14B.

[0034] An end cap 30 has a closed end 32 and an open end 34. The end cap 30 is removably coupled to the valve housing 16 at the open end 34. A flexible diaphragm 36 is coupled between the end cap 30 and the valve housing 16 and is movable from a closed position to and an open position by the fluid energy of the pulse. The second end 20 of the valve housing 16 and the flexible diaphragm 36 form a pressure chamber 22. The valve housing 16 further includes an inlet orifice 24. The inlet orifice 24 is coupled to the pressure chamber 22 by an inlet passage 26. The first and second outlet orifices 14A, 14B are coupled to the pressure chamber 22 by first and second outlet passages 28A, 28B, respectively. The flexible diaphragm 36 seals the pressure chamber 22 from the first and second outlet orifices 28A, 28B when the flexible diaphragm 36 is in the closed position and opens the first and second outlet orifices 28A, 28B to the pressure chamber 22 when the flexible diaphragm 36 is in the open position.

[0035] The valve housing 16 also includes a routing passageway 38 adjacent the inlet passage 26. The routing passageway 38 allows the medication delivery system inlet tube 12 to be secured within the valve housing 16. In one embodiment of the present invention, the end of the inlet tube 12 coated with a solvent and inserted through the inlet passage to the inlet orifice 24. The inlet orifice 24 and the output tube 12 have an interference fit. The solvent bonds the inlet tube 12 and the inlet orifice 24.

[0036] As shown, in one embodiment of the present invention, the open end 34 of the cap 30 has an outer perimeter 38. The outer perimeter 38 includes a ridge 40. The second end 20 of the valve housing 16 includes a detent 42 along its outer perimeter 44. The detent 42 receives the ridge 40 which allows the valve housing 16 and the end cap 30 to be removably snapped together.

[0037] In another aspect of the present invention, the apparatus 10 includes a biasing mechanism 44 coupled between the cap 30 and the flexible diaphragm 36 for biasing the flexible diaphragm 36 towards the closed position. In one embodiment of the present invention, the biasing mechanism 44 includes a biasing spring 46. The biasing spring 46 may be either tubular or conical.

[0038] In another aspect of the present invention, a piston 48 may be juxtaposed between the biasing spring 46 and the flexible diaphragm 36. In one embodiment, the flexible diaphragm 36 includes a piston receiving aperture 50 for receiving a first end 52 of the piston 48.

[0039] As shown, in one embodiment, the piston 48 is hollow and includes a spring receiving chamber 54. The end cap 30 includes a spring positioning pin 56. One end of the spring 46 is seated within the spring receiving chamber 54 and the other end is centered on the spring position pin 56.

[0040] In another aspect of the present invention, the apparatus 10 includes first and second bushings 58A, 58B which are located within and have an interference fit with the first and second outlet orifices 14A,14B. First and second flow restricting components 60A, 60B are positioned within and have an interference fit with the first and second bushings 58A, 58B, respectively. Flexible outlet tubes (not shown) are coupled to the flow restricting components 60A, 60B to deliver medication to the sites, as needed.

[0041] In one aspect of the present invention, the inner diameter of the flow restricting components 60A, 60B are relatively small, e.g., 0.001 to 0.002 inches and a small manufacturing tolerance. The flow restricting components 60A, 60B are dimensioned to provide a large resistance to the flow of medication relative to resistance provided by the flexible outlet tubes and the sites where the medication is delivered. This assists in controlling the back pressure and thus minimizing the risk of uneven back pressure causing an unequal amount of medication to be delivered to the two sites.

[0042] In another aspect of the present invention, the flexible diaphragm 36 includes an integrally molded O-ring 62 around its outer perimeter 64. The O-ring 62 is press fit within a circular groove 66 in the valve housing 16. The valve housing 16 includes one or more air release apertures 68 which allow air to escape the groove 66 as the O-ring 62 is pressed into the groove 66. The O-ring 62 and the groove 66 ensures that the outer perimeter 64 is coupled to the valve housing, thereby forming the pressure chamber 22.

[0043] In operation, the medication delivery system delivers medication through the inlet tube 12 in pulses. With reference to FIG. 8, when the flexible diaphragm 36 is in the closed position, the flexible diaphragm 36 creates a seal on the outlet valve seats. As fluid is pumped in, a pressure is created (P_(inlet)) within the pressure chamber 22. With the flexible diaphragm 36 in the closed position, no flow of medication is allowed from the pressure chamber 22 to the output orifice 14A, 14B. Thus, while the flexible diaphragm 36 is in the closed position, the pressure at the outlet orifices 14A, 14B (P_(outlet)) is substantially zero.

[0044] When the “pulse” of medication from the medication delivery system begins, P_(inlet), quickly ramps up from a non-zero value. When the force exerted by the pressurized medication within the pressure chamber 22 on the flexible diaphragm 36 is great enough to overcome the force exerted by the biasing mechanism 44 (P_(T)), the flexible diaphragm 36 is moved from the closed position towards the open position (t₁). After the flexible diaphragm 36 is moved away from the closed position, fluid flows out of the valve and ramps down towards a non-zero value until the force exerted by the biasing mechanism 44 overcomes the force exerted on the flexible diaphragm by the medication within the pressure chamber 22 (t₂). The rate of fluid flow and therefore pressure decrease is controlled by the flow restricting components 60A, 60B. This control is important since too low of a restriction would not force a complete opening of the valve. In that case the restriction of flow across the valve seats would be significant and minor variations in manufacturing tolerances and/or finishes would control the flow resistance and resultant distribution. With proper flow restrictor selection, the apparatus 10 fully opens and this does not occur.

[0045] Likewise, when the flexible diaphragm 36 is moved away from the closed position, P_(outlet) quickly ramps up to a pressure substantially equal to or slightly less than P_(inlet). While the flexible diaphragm 36 is open, P_(inlet) tracks P_(outlet). Since the resistance seen at the first and second orifices 14A, 14B is a result of the resistance of the first and second flow restricting components 60A, 60B, P_(outlet) at the first and second orifices 14A, 14B are substantially equal. Once the flexible diaphragm 36 closes, P_(outlet) quickly drops back down to substantially zero. $V_{T} = {\int_{T_{D}}^{T_{F}}{{\overset{\bullet}{V}}_{T}\quad {t}}}$

[0046] Since {dot over (V)}={dot over (V)}_(A)+{dot over (V)}_(B), and V_(T)=V_(A)+V_(B)

[0047] then, $V_{A} = {\int_{T_{D}}^{T_{F}}{{\overset{\bullet}{V}}_{A}\quad {t}}}$ $V_{B} = {\int_{T_{D}}^{T_{F}}{{\overset{\bullet}{V}}_{B}\quad {t}}}$

[0048] But we know that $\overset{\bullet}{V} = {\frac{\Delta \quad P}{R_{T}} = {{\frac{P_{outlet} - P_{B}}{R_{T}}\therefore V_{A}} = {\int_{T_{D}}^{T_{F}}{\frac{P_{outlet} - P_{DA}}{R_{A} + R_{DA}}{t}}}}}$ and $V_{B} = {\int_{T_{D}}^{T_{F}}{\frac{P_{outlet} - P_{DB}}{R_{B} + R_{DB}}{t}}}$

[0049] Thus, if P_(outlet)>>|P_(DA)−P_(DB)

[0050] and R>>R_(D)

[0051] and R_(A)≈R_(B)

[0052] then,

V_(A)≈V_(B) (Approximately Equal Flow)

[0053] With reference to FIGS. 9-15, a two site infusion apparatus 110 according to another embodiment of the invention is shown. In FIGS. 9-15, similar parts are labeled the same as in the previous Figures.

[0054] In the second embodiment, an end cap 130, with a generally cylindrical shape, has a closed end 132 and an open end 134. The end cap 130 is removably coupled to the valve housing 16 at the open end 134. For example, the end cap 130 may be bonded to the valve housing 16 by an adhesive. In one aspect of the invention, gaps in the adhesive bonding the end cap 130 to the valve housing 16 allow air to escape. The flexible diaphragm 36 is coupled between the end cap 130 and the valve housing 16 and is movable from a closed position to an open position, as described above.

[0055] As shown, the open end 134 of the cap 130 has an outer perimeter 138. The outer perimeter 138 includes an internal flange 140 which mates with the detent 42 on the valve housing 16 which allows the valve housing 16 and the end cap 130 to be removably snapped together.

[0056] The apparatus 110 includes a biasing mechanism 144 coupled between the cap 130 and the flexible diaphragm 36 for biasing the flexible diaphragm 36 towards the closed position. In one embodiment of the present invention, the biasing mechanism 144 includes a biasing spring 146 with a generally conical shape.

[0057] A piston 148 is juxtaposed between the biasing spring 146 and the flexible diaphragm 136. The piston receiving aperture 50 receives a first end 152 of the piston 148.

[0058] The piston 148 is hollow and includes a spring receiving chamber 154. The end cap 130 includes a spring positioning member 156. One end of the spring 146 is seated against seatings 158 within the spring receiving chamber 154 and the other end is centered on the spring positioning member 156.

[0059] With reference to FIGS. 16-18, an exemplary tube set 68 including the two site infusion apparatus 110 of the second embodiment is shown. The tube set 68 maybe used with a delivery system (not shown). A suitable delivery system is disclosed in U.S. patent application Ser. No. 10/461,939, filed Jun. 13, 2003, which is hereby incorporated by reference.

[0060] The infusion tube set 68 includes a first connector 70 for connection to the delivery system, an on/off clamp 72 and an inline filter 74. Tubing 76 couples the connector 70 with the inline filter 74 and the inline filter 74 with the two site infusion apparatus 110. Tubing 76 also connects the first and second flow restricting components 60A, 60B to second and third connectors 78A, 78B.

[0061] Other aspects and features of the present invention can be obtained from a study of the drawings, the disclosure, and the appended claims.

[0062] Element List

[0063]10 two site infusion apparatus

[0064]12 medication delivery system output tube or inlet tube

[0065]14A first outlet orifice

[0066]14B second outlet orifice

[0067]16 valve housing

[0068]18 first end of valve housing

[0069]20 second end of valve housing

[0070]22 pressure chamber

[0071]24 inlet orifice

[0072]26 inlet passage

[0073]28A first outlet passage

[0074]28B second outlet passage

[0075]30 end cap

[0076]32 closed end

[0077]34 open end

[0078]36 flexible diaphragm

[0079]38 outer perimeter

[0080]40 ridge

[0081]42 detent

[0082]44 biasing mechanism

[0083]46 biasing spring

[0084]48 piston

[0085]50 piston receiving aperture

[0086]52 first end of the piston

[0087]54 spring receiving chamber

[0088]56 spring positioning pin

[0089]58A first bushing

[0090]58B second bushing

[0091]60A first glass tube

[0092]60B second flow restriction

[0093] components

[0094]62 integral O-ring

[0095]64 outer perimeter of flexible diaphragm

[0096]66 groove

[0097]68 tube set

[0098]70 first connector

[0099]72 on/off clamp

[0100]74 inline filter

[0101]76 tubing

[0102]78A second connector

[0103]78B third connector

[0104]110 two site infusion apparatus

[0105]130 end cap

[0106]132 closed end

[0107]134 open end

[0108]138 outer perimeter

[0109]50 140 internal flange

[0110]154 spring receiving chamber

[0111]156 spring positioning member

[0112]158 seatings 

What is claimed is:
 1. An apparatus for use in delivering pain medication to separate locations from a single source of pressurized medication, comprising: a valve housing having a first end and a second end and an inlet passage, the first end including first and second outlet orifices; a cap having a closed end and an open end and being removably coupled to the valve housing at the open end; and, a flexible diaphragm coupled between the cap and the valve housing and being movable from a closed position to an open position, the flexible diaphragm sealing a pressure chamber from the first and second outlet orifices when in the closed position and opening the first and second outlet orifices to the pressure chamber when in the open position, the inlet orifice being coupled to the pressure chamber outlet.
 2. The apparatus, as set forth in claim 1, the pressure chamber being formed by the second end of the valve housing and the flexible diaphragm.
 3. The apparatus, as set forth in claim 1, the inlet orifice being coupled to the pressure chamber by an inlet passage.
 4. The apparatus, as set forth in claim 1, the first and second outlet orifices being coupled to the pressure chamber by first and second outlet passages.
 5. An apparatus, as set forth in claim 1, wherein the open end of the cap has an outer perimeter, the outer perimeter having a ridge.
 6. An apparatus, as set forth in claim 5, wherein the second end of the valve housing includes a detent along its outer perimeter adapted to receive the ridge.
 7. An apparatus, as set forth in claim 1, further comprising a biasing spring coupled between the cap and the flexible diaphragm for biasing the flexible diaphragm towards the closed position.
 8. An apparatus, as set forth in claim 7, further comprising a piston having juxtaposed between the biasing spring and the flexible diaphragm.
 9. An apparatus, as set forth in claim 8, the flexible diaphragm including a piston receiving aperture for receiving a first end of the piston.
 10. An apparatus, as set forth in claim 9, the piston having a spring receiving chamber located at a second end.
 11. An apparatus, as set forth in claim 7, the cap having a spring positioning pin, the spring being centered on the spring positioning pin.
 12. An apparatus, as set forth in claim 1, further comprising first and second bushings located within the first and second outlet orifices, respectively.
 13. An apparatus, as set forth in claim 12, further comprising first and second flow restricting components located within the first and second bushings, respectively.
 14. An apparatus, for use in delivering pain medication to separate locations from a single source of pressurized medication, comprising: a valve housing having a first end and a second end, the first end including first and second outlet orifices; a cap having a closed end and an open end and being removably coupled to the valve housing at the open end; a flexible diaphragm coupled between the cap and the valve housing and being movable from a closed position to an open position, the second end of the valve housing and the flexible diaphragm forming a pressure chamber, the valve housing further including an inlet orifice, the inlet orifice being coupled to the pressure chamber by an inlet passage, the first and second outlet orifices being coupled to the pressure chamber by first and second outlet passages, respectively, the flexible diaphragm sealing the pressure chamber from the first and second outlet orifices when in the closed position and opening the first and second outlet orifices to the pressure chamber when in the open position.
 15. An apparatus, as set forth in claim 11, wherein the open end of the cap has an outer perimeter, the outer perimeter having a ridge.
 16. An apparatus, as set forth in claim 15, wherein the second end of the valve housing includes a detent along its outer perimeter adapted to receive the ridge.
 17. An apparatus, as set forth in claim 14, further comprising a biasing spring coupled between the cap and the flexible diaphragm for biasing the flexible diaphragm towards the closed position.
 18. An apparatus, as set forth in claim 17, further comprising a piston having juxtaposed between the biasing spring and the flexible diaphragm.
 19. An apparatus, as set forth in claim 18, the flexible diaphragm including a piston receiving aperture for receiving a first end of the piston.
 20. An apparatus, as set forth in claim 19, the piston having a spring receiving chamber located at a second end.
 21. An apparatus, as set forth in claim 17, the cap having a spring positioning pin, the spring being centered on the spring positioning pin.
 22. An apparatus, as set forth in claim 14, further comprising first and second bushings located within the first and second outlet orifices, respectively.
 23. An apparatus, as set forth in claim 22, further comprising first and second flow restricting components located within the first and second bushings, respectively. 